UB-VV111 granted FDA fast track designation for the treatment of R/R LBCL and CLL

On September 30, 2025, the U.S. Food and Drug Administration (FDA) granted fast track designation to UB-VV111, an investigational, off-the-shelf lentiviral vector-based gene therapy that generates CD19-directed chimeric antigen receptor (CAR) T cells in vivo, for the treatment of patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL) after ≥2 prior lines of therapy.¹ 

Previously, on July 31, 2024, the FDA cleared the investigational new drug (IND) application for UB-VV111 for the treatment of patients with hematologic malignancies.² An ongoing phase I trial (NCT06528301) is assessing the safety and efficacy of UB-VV111 in patients with R/R CD19+ LBCL or CLL.¹

UB-VV111 was designed to potentially address some of the limitations of traditional ex vivo autologous CAR T-cell therapy, such as manufacturing costs, waiting times, complex procedures, and limited access.¹